Nigella sativa oil composition

Abstract

The present invention is directed to composition comprising Nigella sativa (NS) oil, wherein said oil comprises thymoquinone (TQ) at a concentration of at least 2% (w/w). The composition is further characterized by having a much lower free fatty acid concentration than prior art compositions. The composition, which has anti-inflammatory activity, may be formulated for oral administration to a mammalian subject, for the purpose of preventing or treating inflammatory conditions and other disorders.

The invention claimed is: 
     
       1. A unit dosage form for oral administration, comprising a composition which comprises  Nigella sativa  (NS) oil, an oil diluent, p- cymene and carvacrol, wherein:
 said  Nigella sativa  oil comprises thymoquinone (TQ) at a concentration of at least 2% (w/w) and free fatty acids (FFA), and the ratio of TQ to FFA is greater than 1.2:1; 
 the ratio of TQ to p-cymene is in a range of 2.5:1-4:1; and 
 TQ and p-cymene of said composition synergistically inhibit NO production. 
 
     
     
       2. The unit dosage form according to  claim 1 , wherein the TQ concentration is at least 3% (w/w). 
     
     
       3. The unit dosage form according to  claim 1 , wherein the p-cymene concentration is at least 0.8% (w/w). 
     
     
       4. The unit dosage form according to  claim 1 , wherein the concentration of carvacrol is less than 0.1% (w/w). 
     
     
       5. The unit dosage form according to  claim 1 , wherein the concentration of FFA is less than 3% (w/w). 
     
     
       6. The unit dosage form according to  claim 1 , comprising  Nigella sativa  (NS) oil, wherein said oil comprises thymoquinone (TQ) at a concentration of at least 2% (w/w), p-cymene at a concentration of at least 0.8% (w/w), carvacrol at a concentration of not more than 0.1% and FFA at a concentration of less than 3% (w/w). 
     
     
       7. The unit dosage form according to  claim 1 , wherein said unit dosage form is selected from the group consisting of a soft gel capsule, a hard-shell capsule, a bulk liquid, a tablet, a caplet, and other pharmaceutically acceptable oral dosage forms.